Genome Statute and Legislation Database

This bill creates the Genetic Information privacy Act. The bill prohibits any person from obtaining, analyzing, or disclosing genetic information without the written authorization of the individual to whom the information pertains and requires a separate written authorization for each separate disclosure of an individual's genetic information, with some exceptions such as for law enforcement. The bill permits disaggregated and anonymized data to be used in the manner specified that was collected before the bill's enactment without the authorization described above. The bill also permits the use of disaggregated and anonymized data, as specified, if written authorization is obtained and the data is used for a purpose authorized by the individual to whom the information pertains. Measure failed.

Rapid Whole Genome Sequencing, including individual sequencing, trio sequencing for a parent or parents and their baby, and ultra-rapid sequencing, is a covered benefit for any Medi-Cal beneficiary who is one year of age or younger and is receiving inpatient hospital services in an intensive care unit. Carries over to 2022.

Tests for genetic characteristics may not be required to determine insurability for life and disability income insurance except for policies contingent on review or testing for other diseases and conditions and only with informed consent. Policies may only limit benefits otherwise payable if loss is caused or contributed to by the presence or absence of genetic characteristics if the insurer imposes limitations for other medical conditions that present an increased risk. A life or disability income insurer may not request a genetic test to determine eligibility for hospital, medical or surgical insurance coverage or coverage under a nonprofit hospital service or health care service plan. The statutes set forth civil and criminal penalties for violations.

Prohibits an individual or group health care service plan contract or health insurance policy issued, amended, delivered, or renewed on or after January 1, 2021, from requiring prior authorization for genetic biomarker testing for an enrollee or insured with metastatic or advanced stage 3 or 4 cancer. Died.

This bill continue the exemption to informed consent requirements for human subjects in the event of a life-threatening emergency indefinitely. The existing exemption is set to expire on January 1, 2014. Approved by the Governor on Oct. 4, 2013.

These statute sections contain provisions from 2011 CA SB 559, referred to as CalGINA. The opportunity to seek, obtain, and hold employment without discrimination because of genetic information, is recognized as a civil right. It is an unlawful employment practice, unless based on a bonafide occupational qualification, to subject any employee, applicant or other person to a test for the presence of a genetic characteristic. In addition, a person in the State of California may not, on the basis of genetic information, be unlawfully denied full and equal access to the benefits of, or be unlawfully subjected to discrimination under, any program or activity that is conducted, operated, or administered by the state or by any state agency, is funded directly by the state, or receives any financial assistance from the state.

This bill states that it is the intent of the Legislature to enact legislation to protect individuals from the unauthorized use of their genetic information, ensure that genetic information is personal information that is not collected, stored, or disclosed without the individual's authorization, provide protections for the collection, storage, and authorized use of genetic information, and promote the use of genetic information for legitimate reasons, including, but not limited to, health care, research, advancement of medicine, and educational purposes, as the field of genomics advances. Died.

Amends existing law to protect the privacy and security of computerized data, including personal information, owned or licensed by an agency. This bill adds genetic data to the scope of personal information under the law. Genetic data is defined as any data that results from the analysis of a biological sample of an individual, or from another source enabling equivalent information to be obtained, and concerns genetic material. Genetic material includes, but is not limited to, deoxyribonucleic acids (DNA), ribonucleic acids (RNA), genes, chromosomes, alleles, genomes, alterations or modifications to DNA or RNA, single nucleotide polymorphisms (SNPs), uninterpreted data that results from analysis of the biological sample or other source, and any information extrapolated, derived, or inferred therefrom. 10/5/21 Approved by the Governor. Effective 1/1/2022.

Establishes the Commission on the State of Hate. Requires the commission to advise the Legislature, the Governor, and state agencies on, among other things, policy recommendations to promote intersocial education designed to foster mutual respect and understanding among California�s diverse population. Appointees to the commission are comprised of experts in combating hate, intolerance, and discrimination on the basis of various factors such as genetic information. Died.

Prohibits a policy or contract that covers a small employer, as defined in Section 1304(b) of PPACA and in Section 1357.500, or health care service plans offered outside the American Health Benefit Exchange required by PPACA from establishing rules for eligibility, including continued eligibility, of an individual, or dependent of an individual, to enroll under the terms of the policy or contract based on health status-related factors, including genetic information. Approved by the Governor May 9, 2013.

All testing results and personal information from hereditary disorders programs obtained from any individual, or from specimens from any individual, is confidential and is considered a confidential medical record except for information that the individual, parent, or guardian consents to be released, provided after being fully informed of the scope of the information requested to be released, of all of the risks, benefits, and purposes for the release, and of the identity of those to whom the information will be released or made available, except for data compiled without reference to the identity of any individual, and except for research purposes, provided that pursuant to the Common Rule The research must first be reviewed and approved by an IRB. The health department, any entities approved by the department, and researchers must maintain the confidentiality of patient information and blood samples in the same manner as other medical record information with patient identification and may use it only for approved research to (1) identify risk factors for children's and women's diseases;(2) research to develop and evaluate screening tests;(3) research to develop and evaluate prevention strategies; and (4) research to develop and evaluate treatments. The State Committee for the Protection of Human Subjects (CPHS) must determine if all of the if specified criteria are met for purposes of ensuring the security of a donor's personal information, before any blood samples are released pursuant for research purposes.

Requires every health care service plan contract, except a specialized health care service plan contract to provide coverage for genetic testing for hereditary nonpolyposis colorectal cancer (HNPCC) under certain circumstances. Died.

Prohibits any person or other entity whose business includes performing appraisals of residential real property from discriminating against any person in making available those services, or in the performance of those services, because of various characteristics, including genetic information. Requires every contract for the sale of real property to contain a notice regarding improper or illegal considerations such as genetic information in appraisal of property. 10/5/21 Approved by the Governor. Effective 1/1/2022.

Requires any contracting entity that contracts with independent contractors to provide services to, on behalf of, or through the contracting entity on a freelance or per-gig basis, or virtual platform that enables third parties, including independent contractors, to transact with one another for services, or through which independent contractors can market, promote, or advertise their services to third parties, to maintain a written policy against the discrimination of an independent contractor on the basis of genetic information and other factors. Summary based on version of bill as amended on 5/6/2020 when all language from prior introduced version of bill was stricken. Died.

A stop-loss carrier must offer coverage to all employees and dependents of employees of a small employer to which it issues a stop-loss insurance policy and may not exclude any employee or dependent on the basis of an actual or expected health status-related factor, including genetic information. Approved by the Governor October 1, 2013.

Provides for the protection of human subjects participating in medical experiments. Enacts the Experimental Subject's Bill of Rights, which details informed consent requirements.

Requires a health care service plan contract or a health insurance policy that is issued, amended, or renewed on or after January 1, 2015, to provide coverage for genetic testing for Lynch syndrome. Died.

Genetic information the property of the individual, and written consent is required for its disclosure other than for diagnosis, treatment or therapy. Health care entities may not retain or use genetic information for non-therapeutic purposes or request or require a genetic test; however, test results may be used on a limited basis to make payment decisions. Exceptions under the law include the use of genetic information for scientific research if the identity of the individual to whom the genetic information pertains is not disclosed to a third party other than the individuals physician with written consent. The law provides remedies for individuals whose rights are violated.

Amends the provision requiring health_insurance_coverage for mammography for an individual with a genetic predisposition. The amended version of the statute refers to guidelines of professional associations to determine coverage requirements. May 16, 2019 Signed by the Governor.

Amends the health care coverage law for breast cancer screening by requiring coverage for a person with an increased lifetime risk of breast cancer determined by a risk factor model such as Tyrer-Cuzick, BRCAPro, or Gail. 05/02/2016 In Senate Committee on State, Veterans, & Military Affairs. Postponed Indefinitely.

Genetic information is the property of the individual to whom it pertains. Release of genetic information that identifies the person tested for purposes other than diagnosis, treatment and therapy requires specific written consent. Exemptions under the law include some uses by research facilities. researchers may use genetic testing information for scientific research as long as the identity of any individual to whom the information pertains is not disclosed to any third party except that the individuals identity may be disclosed to the individuals physician with written consent. Group disability or long-term care insurers that receive genetic information may not seek, use or keep the information for any non-therapeutic or underwriting purpose. Life insurers and individual disability insurers may not perform a genetic test without informed consent. Penalties are set forth for unfair trade practices with respect to group disability and long-term care insurance.

Creates the Colorado privacy Act. Prohibits the processing of a consumer's sensitive data without first obtaining the consumer's consent. Sensitive data includes genetic or biometric that may be processed for the purpose of uniquely identifying an individual. 7/7/2021 Governor signed. Effective July 1, 2024.

Establishes the parent's bill of rights. Requirements set forth in the bill include parental written consent before any record of a minor child's blood or DNA is made, shared or stored unless required by law or court order. 02/13/2020 House Committee on State, Veterans, & Military Affairs Postpone Indefinitely.

Prohibits direct primary health care providers from discriminating in the selection of patients on the basis of genetic information and other protected classes.

This bill prohibits the reduction of an employees permanent total disability when the disability is a result of a work-related injury or a work-related injury combined with a congenital, genetic or similar conditions except that the law does not apply to reductions in recovery or apportionment allowed pursuant to Colorado Supreme Court decision in Anderson v. Brinkhoff, 859 P.2d 819, (Colo. 1993). Signed into law June 2, 2008.

This bill amends definitions in the Colorado genetic nondiscrimination in health insurance law. The bill also adds a new section to the Colorado statutes pertaining to limitations on disclosure of genetic information and allows the use of genetic information by research facilities provided that the information is not disclosed to third parties other than to an individual's physician with his or her consent. Signed by the Governor May 25, 2010.

Concerns a study of consumer protection regulation of digital communications platforms. Introduced version included a provision related to sensitive data such as genetic data. However, this provision was deleted from the engrossed version of the bill. Died.

This bill amends section 10-3-1104.6 of the statutes by modifying a provision on limitations on disclosure of genetic information. The list of public health entities exempt from limitations on disclosure when conducting certain activities is reworded to include county, district or municipal public health agencies. Signed by the Governor on June 10, 2010.

Amends existing coverage requirements for breast cancer screening with mammography for individuals with a genetic predispoition to breast cancer. Requires all sickness and accident insurance policies to provide coverage for breast imaging for all individuals possessing at least one risk factor for breast cancer, including a family history of breast cancer, being 40 years of age or older, or a genetic predisposition to breast cancer. Died.

Health-status related factor is defined to include genetic information in Title 10 Article 16, which pertains to health care coverage.

This bill amends existing statutes pertaining to mammography coverage for persons with a predisposition to breast cancer by amending provisions related to copayments and deductibles and the frequency of mammography coverage requirements (breast cancer screening with mammography required annually.) Signed by the Governor on May 13, 2013.

This bill requires a state agency or educational institution to obtain consent from parents or eligible students prior to collecting certain data, including biometric records. Biometric records are defined to include DNA. Died.

The law requires breast cancer screening with mammography annually for persons with a predisposition to breast cancer.

Prohibits direct primary health care providers from discriminating in the selection of patients on the basis of genetic information and other protected classes. 4/24/2017 Signed Act.

Establishes a parental bill of rights. Requirements include parental consent in writing before any record of a minor child's blood or DNA is made, shared, or stored, unless such blood or DNA is otherwise required by law or court order. Died.

Prohibits insurers, health care centers or fraternal benefit societies from purchasing information from direct-to-consumer genetic testing; requesting or requiring that a person disclose this information; or using such information in connection with the issuance, extension, renewal or withholding of an annuity, life insurance or health insurance. Insurers may not make provision of any insurance coverage, benefit, rate or term based on a requirement to undergo genetic testing or the results of a genetic test of an individual's family unless the results are in the individual's medical record. Died.

Creates a penalty for the unauthorized public photography of an individual with a genetic or medical condition. Died.

Requires health_insurance_coverage for genetic cystic fibrosis screenings for women. Died.

Adds tomosynthesis to health_insurance_coverage requirements if a woman is believed to be at increased risk for breast cancer due to family history or prior personal history of breast cancer, positive genetic testing or other indications as determined by a woman's physician or advanced practice registered nurse. June 2, 2016 Approved. Effective January 1, 2017.

This bill amends the state genetic nondiscrimination law for employment by creating an exemption for state or local law enforcement, the department of public safety and the division of scientific services that allows those entities to request or require employees to provide genetic information for the purpose of detecting contamination of samples examined by the division of scientific services. Measure failed.

Requires health_insurance_coverage, without any out-of-pocket expense, for: (1) diagnostic and screening mammograms, breast ultrasounds and magnetic resonance imaging of breasts for all insureds; (2) breast biopsies for all insureds, and (3) prophylactic mastectomies and breast reconstruction surgery for all insureds who have the harmful variant of breast cancer gene one (BRCA1), breast cancer gene two (BRCA2) or any similar gene variant that materially increases breast cancer risk. 1/27/2021 Referred to Joint Committee on Insurance and Real Estate.

The Health Commissioner must review and approve research proposals to be conducted using personally identifiable information in the newborn screening system or requiring contact with affected individuals.

Requires that all research proposed to be conducted using personally identifiable information in the newborn screening system or requiring contact with affected individuals shall be reviewed and approved in advance by the health commissioner. 6/23/2017 Signed by the Governor. Effective 10/1/2017.

Adds tomosynthesis to health_insurance_coverage requirements if a woman is believed to be at increased risk for breast cancer due to family history or prior personal history of breast cancer, positive genetic testing or other indications as determined by a woman's physician or advanced practice registered nurse. Died.

Requires individual health insurance policies to provide coverage for diagnostic and screening mammograms under certain circumstances. Positive genetic testing for the harmful variant of breast cancer gene one, breast cancer gene two or any other gene variant that materially increases the insured's risk for breast cancer fulfills the criteria for required coverage. Died.

The statute provides coverage of specified services for women who meet the age requirements set forth in the statute. If a woman is believed to be at increased risk for breast cancer due to 1) family history or prior personal history of breast cancer or 2) positive genetic testing or other indications as determined by a woman's physician advanced practice registered nurse, individual and group health insurers must provide a mammogram, which may be provided by breast tomosynthesis at the option of the woman covered under the policy, and comprehensive ultrasound screening of an entire breast or breasts. Ultrasound screening is provided only if a mammogram demonstrates heterogeneous or dense breast tissue based on the Breast Imaging Reporting and Data System established by the American College of Radiology.

Creates a health data collaborative working group to examine and make recommendations regarding (1) precision medicine and personalized health; (2) economic growth initiatives for businesses working in certain scientific areas; (3) health data access, privacy and security initiatives; and (4) platforms for collecting health data in order to understand the interplay between genetic, behavioral and environmental factors in the incidence of disease or illness. 6/30/2017 Signed by the Governor. Effective immediately.

Requires a study of the link between the abnormal genes associated with breast and ovarian cancers and the nerve death associated with Alzheimer's disease to improve diagnosis, risk assessment and treatment of disease. Died.

Establishes a framework for controlling and processing personal data. Establishes responsibilities and privacy protection standards for data controllers and processors. Grants consumers the right to access, correct, delete and obtain a copy of personal data and to opt out of the processing of personal data for the purposes of targeted advertising. Sensitive data is defined as personal data that includes the processing of genetic or biometric data for the purpose of uniquely identifying a natural person. Died.

Prohibits insurers, health care centers and fraternal benefit societies from, in connection with the issuance, withholding, extension or renewal of an annuity or an insurance policy for life, credit life, disability, long-term care, accidental injury, specified disease, hospital indemnity or credit accident insurance: (1) requesting, requiring, purchasing or using information obtained from an entity providing direct-to-consumer genetic testing without the informed written consent of the individual who has been tested; (2) conditioning insurance rates, the provision or renewal of insurance coverage or benefit or other conditions of insurance for an individual on a requirement or agreement that the individual undergo genetic testing; and (3) conditioning insurance rates, the provision or renewal of insurance coverage or benefit or other conditions of insurance for an individual on the results of any genetic testing of a member of the individual's family unless the results are contained in the individual's medical record.